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Antiretroviral Therapy Intensification With Raltegravir or Addition of Hyper-immune Bovine Colostrum in HIV-1 Infected Patients With Suboptimal CD4+ T Cell Response (CORAL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kirby Institute
ClinicalTrials.gov Identifier:
NCT00772590
First received: October 14, 2008
Last updated: July 23, 2012
Last verified: July 2012
History of Changes
Results First Received: May 6, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Raltegravir
Drug: Hyper-immune Bovine Colostrum
Other: raltegravir placebo
Other: Hyper-immune Bovine Colostrum placebo
Drug: raltegravir and hyper-immune bovine colostrum

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
100 patients were screening at 20 clinical sites in Australia

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
25 of 100 patients screened did not meet study inclusion criteria and were excluded from study

Reporting Groups
  Description
Raltegravir + Hyper-immune Bovine Colostrum Raltegravir and hyper-immune bovine colostrum
Hyper-immune Bovine Colostrum Hyper-immune bovine colostrum and Raltegravir placebo
Raltegravir Raltegravir and Hyper-immune Bovine Colostrum placebo
Placebo Raltegravir placebo and hyper-immune bovine colostrum placebo

Participant Flow:   Overall Study
    Raltegravir + Hyper-immune Bovine Colostrum     Hyper-immune Bovine Colostrum     Raltegravir     Placebo  
STARTED     19     19     18     17  
COMPLETED     19     19     18     17  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Raltegravir + Hyper-immune Bovine Colostrum Raltegravir and hyper-immune bovine colostrum
Hyper-immune Bovine Colostrum Hyper-immune bovine colostrum and Raltegravir placebo
Raltegravir Raltegravir and Hyper-immune Bovine Colostrum placebo
Placebo Raltegravir placebo and hyper-immune bovine colostrum placebo
Total Total of all reporting groups

Baseline Measures
    Raltegravir + Hyper-immune Bovine Colostrum     Hyper-immune Bovine Colostrum     Raltegravir     Placebo     Total  
Number of Participants  
[units: participants]
 		  19     19     18     17     73  
Age  
[units: participants]
 		         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     18     18     17     16     69  
>=65 years     1     1     1     1     4  
Age  
[units: years]
Mean ± Standard Deviation 		  52  ± 11     56  ± 9     50  ± 10     55  ± 10     53  ± 10  
Gender  
[units: participants]
 		         
Female     2     1     0     1     4  
Male     17     18     18     16     69  
Region of Enrollment  
[units: participants]
 		         
Australia     19     19     18     17     73  



  Outcome Measures

1.  Primary:   Mean Change From Baseline CD4+ Cell Count   [ Time Frame: 24 weeks ]
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  Serious Adverse Events
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Time Frame Baseline to week 24
Additional Description No text entered.

Reporting Groups
  Description
Raltegravir + Hyper-immune Bovine Colostrum Raltegravir and hyper-immune bovine colostrum
Hyper-immune Bovine Colostrum Hyper-immune bovine colostrum and Raltegravir placebo
Raltegravir Raltegravir and Hyper-immune Bovine Colostrum placebo
Placebo Raltegravir placebo and hyper-immune bovine colostrum placebo

Serious Adverse Events
    Raltegravir + Hyper-immune Bovine Colostrum     Hyper-immune Bovine Colostrum     Raltegravir     Placebo  
Total, serious adverse events          
# participants affected / at risk     1/19 (5.26%)     0/19 (0.00%)     1/18 (5.56%)     1/17 (5.88%)  
Cardiac disorders          
Hosp. for chest pain † 1        
# participants affected / at risk     1/19 (5.26%)     0/19 (0.00%)     0/18 (0.00%)     0/17 (0.00%)  
Respiratory, thoracic and mediastinal disorders          
Hosp. for possible Influenza A † 1        
# participants affected / at risk     0/19 (0.00%)     0/19 (0.00%)     0/18 (0.00%)     1/17 (5.88%)  
Skin and subcutaneous tissue disorders          
Hosp. For cellulitis † 1        
# participants affected / at risk     0/19 (0.00%)     0/19 (0.00%)     1/18 (5.56%)     0/17 (0.00%)  
† Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (10.0)




  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Effect of interventions only measured in peripheral blood  


Results Point of Contact:  
Name/Title: Sean Emery
Organization: Kirby Institute, University of New South Wales
phone: +612 938509900
e-mail: semery@kirby.unsw.edu.au


Publications of Results:


Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT00772590     History of Changes
Other Study ID Numbers: NCHECR-CORAL 1
Study First Received: October 14, 2008
Results First Received: May 6, 2012
Last Updated: July 23, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration